UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028805 |
|---|---|
| Receipt number | R000032933 |
| Scientific Title | Single arm prospective observational study for severe heart failure patients repeating hospitalization (multicenter study) |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2019/02/25 12:52:26 |
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Basic information
Public title
Single arm prospective observational study for severe heart failure patients repeating hospitalization (multicenter study)
Acronym
Single arm prospective study for severe HF patients repeating hospitalization
Scientific Title
Single arm prospective observational study for severe heart failure patients repeating hospitalization (multicenter study)
Scientific Title:Acronym
Single arm prospective study for severe HF patients repeating hospitalization
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the characteristics of the change in vital signs before cardiac failure exacerbation obtained from a noninvasive chest attachment type device and a wireless sensor with communication tools.
Basic objectives2
Others
Basic objectives -Others
Safety,Efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Re-hospitalization caused by heart failure, all deaths during the study period(0.5 year).
Key secondary outcomes
1) An elevation to more than 1000pg/ml of B-type peptide during the study period.
2) The reason why patients dropped out.
3) An expression of adverse events.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who hospitalized caused by severe heart failure within a year.
2) Patients classified NYHA II or III or IV.
3) Patients who agreed to participate in this research by themselves.
4) Patients who were over 20 years old when they agreed to participate in this research.
Key exclusion criteria
1) Patients who wear pace makers, ICD and CRT(D), or are supposed to wear them.
2) Patients who are valued as inappropriate by a doctor to participate in this research.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Kinugawa |
Organization
University of Toyama
Division name
Second Department of Internal Medicine
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7297
kinugawa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Joho |
Organization
University of Toyama
Division name
Second Department of Internal Medicine
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7297
Homepage URL
sjoho@med.u-toyama.ac.jp
Sponsor or person
Institute
1) University of Toyama
2) Tokyo Metropolitan Geriatric Hospital
Institute
Department
Personal name
Funding Source
Organization
Secom Science and Technology Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo Metropolitan Geriatric Hospital, SECOM Medical System CO.,LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
富山大学附属病院（富山県）、東京大学医学部附属病院（東京都）、東京都健康長寿医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data analysis in progress.
Management information
Registered date
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032933
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
